The programme has launched two pilot initiatives to facilitate the dialogue between regulators and sponsors or applicants prior to submission of their applications.
One pilot aims to reinforce scientific advice coordination between clinical trial approval and clinical trial design, while the second offers pre-clinical trial application advice on regulatory aspects.
The pilots will continue in 2026. Once completed, learnings will be published to inform future proposals for advice processes offered by the European medicines regulatory network.
Pilots for consolidated advice
The pilots enhance the coordination within the European medicines regulatory network (EMRN) to offer applicants harmonised advice on how to improve the quality of their applications for marketing and/or clinical trial authorisation(s).
In line with EMRN's strategic goals and ACT EU's vision to improve the EU environment for clinical trials, the pilots aim to facilitate the development of safe and effective medicines to the benefit of patients and healthcare in the region.
A list of Member States participating in each pilot is also available.
The pilots are accepting new applications in 2026. Previous applicants can also reapply and are encouraged to choose a different reporting Member State.
Consolidated scientific advice (SAWP-CTCG)
This pilot provides consolidated scientific advice to support applicants in the submission of marketing authorisation and/or clinical trial applications in the EU.
The advice is offered via increased coordination between the European Medicines Agency's (EMA) Scientific Advice Working Party (SAWP) and the Head of Medicines Agencies' (HMA) Clinical Trials Coordination Group (CTCG).
Pre-clinical trial application advice (Pre-CTA)
This pilot provides consolidated technical, regulatory advice on the dossier of a clinical trial application (CTA) prior to its submission in the Clinical Trials Information System (CTIS).
The pilot is coordinated by the Clinical Trials Coordination Group (CTCG).
Interim findings from the pilots
An interim report is now available, providing an overview of the first results from the two pilots.
The report highlights how early dialogue with regulators and aligned scientific and regulatory advice support applicants in designing better clinical trials and submitting their clinical trial applications.
Mapped information on current voluntary procedures
With a view to clarifying the scope of current scientific and regulatory advice activities, the ACT EU initiative has mapped information on current voluntary procedures available from EU regulators on Medicines for human use and collated this information in the form of questions and answers.
The scope of scientific advice options overlaps significantly, with the type of product and applicant being important factors for selecting the optimal option, e.g. products intended for a single or limited number of EU Member State(s), applicants operating nationally, including academic ones opting for national scientific advice.
Key updates
The programme also collated updates on other scientific advice procedures, as shown below.
EMA centralised scientific advice
For scientific advice provided by SAWP and the Committee for Medicinal Products for Human Use (CHMP), EMA clarifies which questions are outside the scope through the following resources:
EMA centralised scientific advice for public health emergencies
EMA's ETF and CHMP also provide centralised scientific advice for medicines targeting a declared or potential public health emergency, and for preparedness, based on articles 15 and 16 of Regulation 123/2022.
For related guidance for developers, see:
Simultaneous national scientific advice (SNSA)
The EU Innovation Network (EU IN) is running an initiative providing national scientific advice from more than one national competent authority at the same time.
For more information on SNSA's purpose, and to access relevant documents such as guidance and application forms, see: EMA website: EU Innovation Network (EU-IN)
SNSA focuses specifically on scientific advice to facilitate clinical trials within the EU.
The optimised SNSA process will continue to complement and provide a bridge between purely national scientific advice and centralised European scientific advice procedures from EMA.
The initiative is expected to inform the development of a final consolidated process for the provision of clinical trial-related advice.
News
The ACT EU workplan for 2026-2027 outlines the initiative's revised objectives and areas of focus, informed by feedback from stakeholders.
New approach brings together clinical trial and ethics expertise to accelerate development of medicines for use ahead of or during emergencies
The ACT EU workplan for 2025-2026 outlines the initiative's areas of focus, which reflect feedback from stakeholders.
